The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.
This is a randomized, 12-week, double-blind, placebo-controlled, study in approximately 1350 adult male and female patients with CIC comparing 2 doses of plecanatide to placebo. The study will be conducted at approximately 180 clinical study sites in the United States (US) and Canada. The primary objective of the study is to evaluate the efficacy and safety of 3.0 and 6.0 mg of plecanatide administered once daily (QD) for 12 weeks in a population of patients with CIC. The study population will include only patients without other causes of constipation or other chronic conditions that could interfere with study assessments. Patients may not take laxatives (with the exception of the study-provided rescue medication, bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation or diarrhea, during study participation. There are 6 scheduled study visits, including the screening and follow-up visits. The planned duration of participation in this study will be 112 days and up to 155 days, with washout and all visit windows considered.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,394
Plecanatide tablets QD for 12 weeks
Matching placebo tablets QD for 12 weeks
Rescue medication
Number of Durable Overall CSBM Responders , Mean Replacement Approach
A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, included at least 3 of the last 4 weeks. A CSBM weekly responder was defined as a patient who has ≥ 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of ≥1 CSBM for that week. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation.
Time frame: 12-week Treatment Period
Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach
A Complete Spontaneous Bowel Movement (CSBM) was a Bowel Movement (BM) that occurred in the absence of laxative use within 24 hours of the BM and the patient reported a feeling of complete evacuation. A weekly responder had 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week.
Time frame: 12-Week Treatment Period
Change From Baseline in SBM (SBMs/Week) Over 12-week Treatment Period, Mean Replacement Approach
The change from baseline in the number of Spontaneous Bowel Movement (SBM) over the 12-week Treatment Period was assessed. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly SBM totals were derived from the daily diary entries reported during the Treatment Period in the BM and Symptom Diary.
Time frame: 12-Week Treatment Period
Change From Baseline in Stool Consistency Score Over the 12-week Treatment Period, Mean Replacement Approach
The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale \[BSFS\] from 1 to 7. 1. = separate hard lumps like nuts (difficult to pass) 2. = sausage shaped but lumpy 3. = like a sausage but with cracks on its surface 4. = like a sausage or snake, smooth and soft 5. = soft blobs with clear-cut edges (passed easily) 6. = fluffy pieces with ragged edges, a mushy stool 7. = watery, no solid pieces (entirely liquid)
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Synergy Research Site
Birmingham, Alabama, United States
Synergy Research Site
Dothan, Alabama, United States
Synergy Research Site
Gulf Shores, Alabama, United States
Synergy Research Site
Huntsville, Alabama, United States
Synergy Research Site
Mobile, Alabama, United States
Synergy Research Site
Mesa, Arizona, United States
Synergy Research Site
Phoenix, Arizona, United States
Synergy Research Site
Phoenix, Arizona, United States
Synergy Research Site
Tempe, Arizona, United States
Synergy Research Site
Tucson, Arizona, United States
...and 179 more locations
Time frame: 12-Week Treatment Period
Change From Baseline in Straining Score Over 12-Week Treatment Period, Mean Replacement Approach
Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly average straining score was derived from the straining scores reported during the Treatment Period in the Daily Symptom Diary. The severity of straining during bowel movements was assessed on a 5-point Likert scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.
Time frame: 12-Week Treatment Period